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BriaCell Therapeu-cs Corp
September 2015
Cancer Management through Immunomodula2on i3
TSX-‐V: BCT OTCQX: ANCCF
Except for historical information, this presentation contains forward-looking statements, which reflect BriaCell’s current expectations regarding future events. These forward-looking statements involve known and unknown risks and uncertainties that could cause BriaCell’s actual results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly and annual filings. The forward-looking statements in this presentation are also based on a number of assumptions which may prove to be incorrect. Forward-looking statements contained in this presentation represent views only as of the date of this presentation and are presented for the purpose of assisting potential investors in understanding BriaCell’s business, and may not be appropriate for other purposes. BriaCell does not undertake to update forward-looking statements, whether written or oral, that may be made from time to time by or on its behalf, except as required under applicable securities legislation. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read BriaCell’s continuous disclosure documents, including its financial statements which are available on SEDAR at www.sedar.com.
Forward-Looking Statements
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Leading Technology: Novel off-the-shelf cancer immunotherapy
Right Time: Second Phase I/IIa clinical trial initiating
Unique Approach: Targeted therapy via companion diagnostic
Large Market Opportunity: $35BN Immunotherapy market by 2020
Strong Team: Experts in immunotherapy & diagnostics
Poised to Unlock Value: Several short- and long-term milestones
Investment Highlights
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Management Board
Dr. Joseph Wagner, President and CEO § Scientist/entrepreneur with 15 years experience in C-level positions at
multiple biotech companies § President & CEO, OncoCyte Corp., where he led development of 3
cancer diagnostic products currently in trials involving over 2000 patients § President & CTO, Cell Targeting, Inc., where he led successful
acquisition by BioTime, Inc. § VP, Neuronyx, Inc. where he led first allogeneic cell therapy program for
heart disease in program partnered with Johnson & Johnson § Raised >$100M in capital in public, private and angel funding rounds as
well as >$20M in non-dilutive grant and collaborative funding
Dr. Charles Wiseman, Founder and CMO § Oncologist with 45 years experience, pioneered chemotherapies § Director, Immunotherapy Lab, St. Vincent’s § Chief, Breast Cancer Basic Research Lab, Univ. of Texas MD Anderson
Hospital & Tumour Institute § Assistant Professor, Dept of Molecular Carcinogenesis & Virology, MD
Anderson; Acting Chief, Division of Oncology, White Memorial Medical Center, Los Angeles
Dr. Markus Lacher, Director of Research & Development § Sr. Scientist at NYSE Listed biotech BioTime for 5 years, including time
alongside BriaCell CEO Dr. Joseph Wagner a § Founded T-Cell Therapeutics Inc., a California based biotech dedicated
to developing immunotherapies for prostate cancer § Author of 1st Sequencing of Nuclear DNA of 5 clinical-grade human
embryonic stem cell lines, published in Stem Cell Research
Dr. Saeid Babaei, Chairman § Currently CEO of biotech AbCelex which recently obtained
investment from a top agtech/biotech VC in the US § Vice President, Lorus Therapeutics, where he was responsible
for large turnaround including out-licensing a Phase-III cancer immuno-oncology program to a private equity firm in the US
§ Director of Corporate Development at Northern Therapeutics, which was successfully partnered to United Therapeutics
Isaac Maresky, Director § Responsible for identifying, supporting BriaCell from early
development § Investment Banker, Sunel Securities focused on identifying &
executing investments § Investment banker, Standard Chartered Investment Bank, M&A
Group
Rahoul Sharan, Director and CFO § Chairman, Potash Ridge, Issuer on TSX with largest Potash
asset in USA § Partner, S&P Group, where he has led financings in excess of
$100M § Public Accountant at Coopers & Lybrand in tax & audit of large
companies
BriaCell Management and Board
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“The Next Wave in Cancer, Immuno-Oncology therapies that harness the body’s own immune system to fight cancer have shown exciting promise in transforming
cancer treatment” -Morgan Stanley
Immunotherapies are expected to be a more targeted, less toxic approach to managing cancer; more likely to prevent recurrence
2010 -‐ $1.6B global cancer
vaccine market
Aug 23, 2013: AstraZeneca/MedImmune acquires Amplimmune (anti-PD-1) for $225M + up to $275M
June 1, 2014: GSK enters deal with Adaptimmune for developing engineered autologous T cells therapies for $350M
June 20, 2014: Kite NASDAQ IPO, $474mm valuation goes to $1B – engineered autologous T cell therapies from NIH
Nov 17, 2014: Pfizer-Merck KgA co-development deal for Merck’s anti PDL-1. Pfizer pays $850M + $2B in milestones + equal share of products’ profits
Dec 18, 2014: Juno NASDAQ IPO $2B valuation, exceed $4B valuation in < one month
2020 – Global immunotherapy market forecasted to reach $35B
(Citigroup)
“By 2020, immunotherapies will be treating 60% of all cancers
and earning $35b per year” -Citibank (Head of Healthcare)
Immunotherapies: The Way of the Future in the Fight Against Cancer
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§ Virtually all tumors express “mutant” proteins that should be recognized by immune system as “alien”
§ Consistent animals study and human clinical evidence of inducible host versus tumor response
§ Clinical studies often demonstrate robust, sometimes Complete Responses in patient subsets
Cancer Immunotherapy The Story The Reality
§ Difficult to predict which patients will demonstrate CR/PR
§ Combination treatments may be necessary for real efficacy
§ Autologous cellular immunotherapies face significant challenges
§ Regardless of challenges, FDA approval and reimbursement pathways are defined for effective cancer immunotherapies
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Modular Immunotherapy: § Cell module
§ Allogeneic “off the shelf” tumor cell § Engineered to secrete GM-CSF
§ Cytokine module § Pretreatment with cyclophosphamide § Post-treatment with interferon-α
§ Result = Broad activator of host-versus-tumor response at low COGs Target Population:
§ Initially 3rd line treatment for late stage breast cancer § Ultimate use in early stage cancers sharing antigen profile of vaccine cell § Maintenance therapy for duration of disease
Proposed Mechanism:
§ Activation of innate immune response § Induction of adaptive immune response § Modulation of acute vascular inflammatory response
BriaCell’s BriaVax™ : Multi-modal, cell-based cancer immunotherapy
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BriaVax™
BriaCell’s Formula for Clinical Success
Combination cancer immunotherapy maximizes therapeutic potential: • Allogeneic breast tumor cell
line + • Transgenic GM-CSF
secretion + • Cyclophosphamide pre-
treatment + • Interferon-α boost
Companion diagnostic to be co-developed during clinical studies: • Gene expression analysis of
blood and tumor samples • Would either predict or
monitor BriaVax™ responsiveness
• Maximizes health outcomes AND health economics
• Minimal additional development costs
BriaVax™ DX
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Dr. C. L. Wiseman (left) helped pioneer chemotherapies before they were
considered a possibility. When he then began developing immunotherapy
vaccines in the 70s, “cancer vaccine” was not even a term, yet he had the vision of a more targeted approach without the side effects of chemo
BriaCell is developing a proprietary tumor cell vaccine –
BriaVaxTM, for patients with advanced breast cancer with
potential applicability to other tumor types
BriaVaxTM, is the end-result of decades of clinical investigation
by Dr. Charles Wiseman, a practicing oncologist with direct
patient interaction
BriaVaxTM already has been tested in 2 Phase I studies with positive safety and evidence of efficacy
BriaCell’s BriaVaxTM Vaccine: Development Story
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First Phase I: § Used unmodified cell line + GM-CSF + cyclophosphamide § N = 14 late stage, treatment-refractory breast cancer patients § No significant adverse treatment-associated events, well tolerated § Median Overall Survival = 12.1 months
Second Phase I: § Used GM-CSF-engineered cell line + cyclophosphamide + interferon-α § N = 4 late stage, treatment-refractory breast cancer patients § No significant adverse treatment-associated events, well tolerated § Median Overall Survival = 35 months § One robust responder with >90% regression during treatment, subsequent
relapse (upon halting treatment) responded to re-treatment
BriaCell’s BriaVaxTM : Clinical Data to Date
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Tumor Regression – Series-I Baseline
Before Treatment 3 Vaccines
6 Weeks Treatment 6 Vaccines
20 Weeks Treatment
Tumor Re-Regression – Series-II Relapsed 3 Additional Vaccines
8 Weeks
7 weeks to restart of treatment
CD40L Levels During Treatment Series-I
CD40L Levels During Re-Treatment Series-II
Second Phase I Study: Regression of Tumors vs Rise of CD40L
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Protocol submitted to FDA: § A single-center trial enrolling up to 24 late stage-IV
breast cancer patients
§ Primary objective is to determine safety and tumor response
§ Designed with ability to amend the trial to evaluate: § Changes in dose and schedule § Use in combination with other medications
or immunotherapies § Application to earlier, more favorable
breast cancer categories § Application to other HER2 positive solid
tumors § Application to solid tumors with antigenic
marker other than HER2
§ Anticipate enrolling first patient = Early Q4 2015
Upcoming Phase-I/II Open Label Clinical Trial
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BriaCell Milestones
2015 2016 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Today
March 10: Completion and submission of Protocol for Phase I/II Clinical Trial for 24 late-stage cancer patients to FDA
June 1: Hired seasoned biotech veteran Dr. Joseph Wagner June 16: Signed Definitive Agreement of Manufacturing of BriaVax under cGMP Facility with University of California, Davis Health Center
July 15: Hired Dr. Markus Lacher, a senior scientist who previously worked with Dr. Wagner
Manufacturing of BriaVax for upcoming Clinical Trial
Initiation of Phase I/II BriaVax Clinical Trial Interim Data from Phase I/II
Clinical Trial Presentation of clinical data at major oncology conferences
Possible filing of additional patents
Draft new protocols for additional Phase II/III studies as counseled by FDA
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Approved to Apply Vaccine to Other Cancers § FDA has already approved BriaCell to test its vaccine on select other cancers for HER-2
positive patients or 15-30% of lung, ovary, prostate, bladder, pancreas, and gastric cancers § If BriaCell can prove its concept on breast cancer, it intends on testing the vaccine on these
cancers as well:
§ Numbers are for USA alone, and only include terminal cases (1.6% of cancers) § Numbers do not include:
I. Preventative cases II. Other cancer types III. HER-2 Negative patients
Market Analysis: Disturbing a Multi-Billion Dollar Market
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Cancer Type Annual Mortality HER-‐2+ Popula-on Poten-al Market Poten-al Market
Americans only 15-‐30% of total at $200k per treatment Including non HER-‐2 breast
Breast 40,000 8,000 $1,600,000,000 $8,000,000,000
Lung 160,000 24,000 $4,800,000,000 $32,000,000,000
Ovary 33,000 4,950 $990,000,000 $6,600,000,000
Prostate 27,000 4,050 $810,000,000 $5,400,000,000
Bladder 14,000 4,200 $840,000,000 $2,800,000,000
Pancreas 14,000 2,100 $420,000,000 $2,800,000,000
Gastric 10,000 2,000 $400,000,000 $2,000,000,000 Total 298,000 49,300 $9,860,000,000 $59,600,000,000
Company Exchange:
Ticker Market Cap Phase Most Partnership Notes
(US $M) Advanced
Celldex Therapeutics, Inc. NasdaqGS:CLDX 2,640 Phase III Therapeutic antibodies, immune system modulators & vaccines
Aduro BioTech, Inc. NasdaqGS:ADRO 1,724 Phase II Immunotherapy with modified-listeria mononcytogenes
NewLink Genetics Corp. NasdaqGM:NLNK 1,558 Phase III Small molecule immunotherapy for oncology conditions
Northwest Biotherapeutics, Inc. NasdaqCM:NWBO 927 Phase III Immunotherapy with dendritic cells loaded with tumor biomarkers
Inovio Pharmaceuticals Inc NasdaqGS:INO 539 Phase II Upenn/Merck Synthetic DNA vaccine based on inactivated or weakened viruses
Oncothyreon Inc. (USA) NasdaqGS:ONTY 374 Phase III Merck Developing L-BLP25 vaccine for non-small cell lung cancer
Compugen Ltd. (USA) NasdaqGM:CGEN 354 Phase III Bayer Antibody-based oncology immunotherapy; recent deal with majors
Galena Biopharma Inc NasdaqCM:GALE 290 Phase III Leica/Teva Node positive HER-2 negative breast cancer
Peregrine Pharmaceuticals NasdaqCM:PPHM 264 Phase II Recently completed Phase II second-line non-small cell lung cancer
Trillium Therapeutics TSX:TR 161 Phase I Immuno-oncology developing antibody-like fusion protein
Scancell Holdings Plc AIM:SCLP 95 Phase I/II SCIB1, plasmid DNA which encodes human antibody for melanoma
ImmunoVaccine Inc. TSX:IMV 85 Phase I/II Recent $5M loan from province of Nova Scotia to begin Phase II
CEL-SCI Corporation AMEX:CVM 70 Phase III Teva/Orient Primary head and neck cancer immunotherapy vaccine
Vical Incorporated NASDAQ:VICL 61 Phase III DNA-based immunotherapeutic to stimulate responses to tumours
ImmunoCellular Therapeutics Ltd. AMEX:IMUC 45 Phase II Autologous dendritic cell-based vaccines, tumor-associated antigens Average (All) 612 Average (Phase I&II): 416 BriaCell Therapeutics Corp TSXV:BCT C$20 Phase I/II Two Phase I studies done, initiating Phase I/II trial in Q4/15
Comps: Entering the Market at Ground-Level Valuation
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Transaction Overview
Bayer (Market Cap: $95B), a German pharmaceuticals giant, agreed to collaborate with Compugen, a small Israeli based immunotherapy company working on developing its anti-body based cancer therapy; market cap since increased from $180M to over $300M
Genentech, a member of the Roche Group (Market Cap: $223B), announced a research collaboration with London based privately owned Immunocore, to develop their immunotherapy involving T Cell Receptors; Soon after, GlaxoSmithKline (Market Cap: $128B) announced another collaboration
Up to $850M; $530M from GSK Ø $220M in preclinical milestone payments Ø $310M for commercialization milestones
Up to $320M from Genentech Ø Up front payment of up to $20M Ø $300M in commercialization milestones
Up to $540M Ø Up front payment of $10M Ø $30M for preclinical activities Ø Up to $500M in milestone payments
GSK, Genentech & Immunocore
June 27th & July 9th, 2013
Bayer & Compugen August 5th, 2013
Precedent Transactions: Majors Entering the Space
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Size
Date Closed Value Price Shares (MM) Note
27-Nov-2014 $2.24 $0.18 12.36
Part of RTO, which closed Nov 27, 2014. Each unit consisted of one common share and one share purchase warrant with a strike price of $0.25 in the first 12 months and a strike of $0.35 for the following 24 months.
Most Recent Financing
Common shares
Warrants
CompensaNon warrants
OpNons
Fully Diluted
84,736,316
13,432,881
746,117
288,011
2,325,000
750,000
175,000
103,487,453
$0.25
$0.18
$0.18
$0.22
$0.22
$0.30
Current outstanding
Exercise price
Capitalization and Latest Financing
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Price $0.23
Market Cap $19.49M
Cash $1.91M
Debt $0.0M
Market Summary (values in Canadian Dollars)
Cedars-Sinai Largest Cancer Care
Center In all of Los Angeles
USC Medical School Discovered first cancer
causing oncogene in 1970
Established by National Cancer Act of 1971
As 1 of 3 original cancer centers
UC Irvine Health Named top 50 hospitals in
US for cancer
“I believe you have a very novel and fascinating finding”
“I enjoyed reviewing your data… the responses in the central
nervous system are quite remarkable”
“Dr. Wiseman demonstrated his skills as an expert clinician…
I find the research of substan.al interest”
“We are looking forward to further progress in
establishing the collaboration”
Sheba Hospital Largest hospital in the country
of Israel
Brain metastases seen regress considered “untouchable”
Collaboration Options: Interest from Top Institutions
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BriaCell Therapeutics: Summary
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§ Developing a fully-patented immunotherapy vaccine for patients with advanced breast cancer with significant near- and long-term milestones on horizon
§ Led by by a seasoned management team devoted to efficient execution of corporate and
scientific objectives § Exceptional clinical trial results to date:
§ Patients have responded to the vaccine, lifespan has been extended by up to 5x what would be expected
§ Vaccine has acted rapidly, and has been shown to be completely safe with no side effects
§ FDA approved for testing on select other cancers for HER-2 positive patients, increasing BriaCell’s target market five-fold
§ Advancing the vaccine into the next clinical trial - up to 24 late-stage breast cancer patients will be tested in order to further solidify the results achieved to date
§ Experienced management team and Board of Directors
§ Currently undervalued compared to immuno-oncology peers
BriaCell Therapeutics Corp
Beverly Hills Cancer Center 8900 Wilshire Blvd, 90211
[email protected] | 1-‐‑888-‐‑485-‐‑6340 | BriaCell.com
TSX-‐‑V: BCT OTCQX: ANCCF